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Phase 2 Study Of AG-013736 As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer

Phase 2
20 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

Phase 2 Study Of AG-013736 As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer

Inclusion Criteria:

- Patients histologically diagnosed as metastatic renal cell cancer with a component of
clear cell cancer.

- Patients who are refractory to cytokine therapy as 1st line.

- Patients who experienced nephrectomy.

- Patients with at least 1 target lesion, as defined by RECIST.

- Patients with no uncontrolled hypertension.

Exclusion Criteria:

- Gastrointestinal abnormalities

- Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4

- Active seizure disorder or evidence of brain metastases.

- Patients with hemoptysis.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment

Outcome Description:

Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.

Outcome Time Frame:

Up to 765 days of treatment at the data cut-off date

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

December 2007

Completion Date:

October 2012

Related Keywords:

  • Carcinoma, Renal Cell
  • AG-013736
  • RCC
  • Phase 2
  • Carcinoma
  • Carcinoma, Renal Cell